Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine— 510(k) K262257
Substantially EquivalentBrainlab SE
FDA 510(k) clearance K262257 for Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine, Substantially Equivalent on 2026-09-30. Applicant: Brainlab SE. Device class: 2.
Summary
This Brainlab SE clearance covers three products: Spine Planning (version 3.0), Spine & Trauma Navigation, and Alignment System Spine. They're filed under OLO, orthopedic stereotaxic instruments, a code for stereotaxic guidance during orthopedic joint or spine surgery.
Class II, 21 CFR 882.4560. The advisory panel is listed as Neurology, even though the code name says orthopedic; the review panel is listed as Orthopedic. It was a Traditional 510(k).
Brainlab filed from Munich, Germany. Review took 90 days (July 2 to September 30, 2026).
Clearance details
- Applicant
- Brainlab SE
- Product code
- Product code OLO
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Munich, DE
Recent devices under product code OLO
view all- K263154 — CarboClear® Cervical Navigated Instruments
- K262506 — Remex Spine Surgery Navigation - Universal Instruments
- K261410 — Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))
- K261205 — SPINEART Navigation Instrument System
- K261024 — TMINI Miniature Robotic System
More clearances from Brainlab SE
view allAdverse events under product code OLO
product code OLO- Death
- 11
- Injury
- 2,799
- Malfunction
- 11,105
- Other
- 1
- Total
- 13,916
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.